Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
NCT ID: NCT01563341
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2012-04-30
2023-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deep Brain Stimulation
Parkinson's disease patients who would otherwise be undergoing subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi).
Deep brain stimulation
Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications).
Interventions
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Deep brain stimulation
Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications).
Eligibility Criteria
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Inclusion Criteria
* Parkinson's Disease (PD) patients in whom optimal medical therapy has failed.
* All patients will have responsivity to levodopa.
* Individuals with normal or mild cognitive impairment.
Exclusion Criteria
* Other significant neurological or psychiatric disease
* Previous brain surgery including pallidotomy or thalamotomy
* Previous placement of other implantable devices
40 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Ryan Uitti
Principal Investigator
Principal Investigators
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Ryan Uitti, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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11-007086
Identifier Type: -
Identifier Source: org_study_id